NGM Bio Provides Business Highlights and Reports First Quarter 2021 Financial Results
May 06 2021 - 4:05PM
NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology
company focused on discovering and developing transformative
therapeutics for patients, today provided business highlights and
reported financial results for the period ending March 31,
2021.
“In the first quarter of 2021, we achieved a key milestone in
our oncology portfolio with the initiation of the randomized,
placebo-controlled component of our NGM120 study in patients with
metastatic pancreatic cancer,” said David J. Woodhouse, Ph.D.,
Chief Executive Officer at NGM. “We also continued to make progress
across our four other ongoing Phase 2 and Phase 2b programs. We
remain on track to report topline data from our Phase 2b ALPINE 2/3
clinical study of aldafermin in patients with NASH in the second
quarter and we expect to complete enrollment in our Phase 2
CATALINA clinical study of NGM621 in patients with geographic
atrophy by mid-year. Our team continues to work diligently to
advance our two lead immuno-oncology product candidates into the
clinic later this year.”
Dr. Woodhouse continued, “We demonstrated strong pipeline and
corporate execution despite the continued challenges presented by
the COVID-19 pandemic and continue to focus on our mission to
translate powerful biology with urgency and rigor to deliver
life-changing medicines.”
Key First Quarter and Recent Highlights
Liver and metabolic diseases
- Anticipate
reporting topline data from the Phase 2b ALPINE 2/3 study of
aldafermin in patients with NASH with liver fibrosis stage 2 or 3
(F2-F3) in the second quarter. ALPINE 2/3 is a Phase 2b
clinical study of aldafermin in patients with biopsy-confirmed NASH
and liver fibrosis F2 or F3. The 24-week study will assess the
efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of
aldafermin compared to placebo. The primary objective of the ALPINE
2/3 study is to evaluate a dose response showing an improvement in
liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at
week 24.
- Continued
enrollment in Phase 2b ALPINE 4 study of aldafermin in patients
with NASH with liver fibrosis stage 4 (F4) and compensated
cirrhosis. NGM continued enrollment in the Phase 2b ALPINE
4 clinical study of aldafermin in patients with biopsy-confirmed
NASH with F4 liver fibrosis and compensated cirrhosis. The 48-week
study is designed to enroll approximately 160 patients and will
assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3
mg doses of aldafermin compared to placebo. The primary objective
of ALPINE 4 is to evaluate a dose response showing an improvement
in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis
at week 48.
- Merck
continued the Phase 2b study of MK-3655 in patients with NASH with
F2-F3 liver fibrosis. In November 2020, Merck initiated a
global Phase 2b multicenter study of MK-3655 for the treatment of
F2-F3 NASH. The 52-week randomized, double-blind study is designed
to enroll approximately 320 patients and will assess the efficacy,
safety and tolerability of 50 mg, 100 mg and 300 mg doses of
MK-3655 compared to placebo. The primary objective of the Phase 2b
study is NASH resolution without worsening of fibrosis after 52
weeks. Merck licensed MK-3655 following NGM’s completion of a
proof-of-concept study. NGM retains an option, at the initiation of
the first Phase 3 clinical trial for MK-3655, to either receive
milestone and royalty payments or to co-fund development and
participate in a global cost and revenue sharing arrangement of up
to 50% for MK-3655.
Retinal diseases
- Expect to
complete enrollment in the Phase 2 CATALINA study of NGM621 in
patients with GA by mid-year. NGM continues to enroll
patients in the Phase 2 CATALINA study, a multi-center, randomized,
double-masked, sham-controlled clinical trial to evaluate the
safety and efficacy of intravitreal (IVT) injections of NGM621
every four weeks or every eight weeks in patients with geographic
atrophy (GA) in one or both eyes secondary to age-related macular
degeneration. NGM anticipates completing enrollment by mid-year.
The primary endpoint is the rate of change in GA lesion area, as
measured by fundus autofluorescence imaging, over 52 weeks of
treatment.
- Presented
Phase 1 safety and pharmacokinetics (PK) data for NGM621 in
patients with GA at the Angiogenesis, Exudation, and Degeneration
2021 - Virtual Edition. Single and multiple IVT injections
of NGM621 appeared safe and well tolerated in this first-in-human
study, with no patients experiencing serious adverse events,
drug-related adverse events, endophthalmitis, intraocular
inflammation or choroidal neovascularization. The serum PK of
NGM621 was linear and dose-proportional. Based on ocular
PK/pharmacodynamics (PD) modeling, NGM believes NGM621 has the
potential for up to an every eight-week dosing regimen.
Cancer
- Initiated a
Phase 2 placebo-controlled component of an ongoing Phase 1/2 study
of NGM120 in January, testing NGM120 as a first-line treatment in
combination with gemcitabine and Abraxane® (paclitaxel protein
bound) in patients with metastatic pancreatic cancer. NGM
initiated a multi-center, randomized, single-blind (sponsor
unblinded), placebo-controlled component of NGM120 in combination
with gemcitabine and Abraxane as a first line treatment in patients
with metastatic pancreatic cancer as part of its ongoing Phase 1/2
trial. This Phase 2 component of the Phase 1/2 study is designed to
enroll approximately 60 patients and will assess the efficacy,
safety and tolerability of NGM120 or placebo in combination with
gemcitabine and Abraxane against both cancer and cancer-related
cachexia endpoints. The Phase 1a/1b dose-finding portion of the
study is still ongoing, and NGM expects to report interim results
from that portion of the study in the second half of the year.
- Continued to
progress two new oncology clinical candidates, NGM707 and NGM438,
toward the clinic. These programs are part of NGM’s
strategy to treat cancer through myeloid reprogramming that
reverses immune suppression in the tumor microenvironment. NGM707
is a dual antagonist antibody that inhibits Immunoglobulin-like
transcript 2 (ILT2) and Immunoglobulin-like transcript 4 (ILT4).
NGM438 is an antagonist antibody that inhibits Leukocyte-associated
immunoglobulin-like receptor 1 (LAIR1). NGM expects to initiate a
first-in-human Phase 1 trial for NGM707 in patients with advanced
solid tumors in mid-2021 and for NGM438 in patients with advanced
solid tumors during the fourth quarter.
Corporate
- Completed a
public offering of common stock. In January, NGM completed
an underwritten public offering of 5,324,074 shares of its common
stock for net proceeds to NGM of $134.6 million, which included the
full exercise by the underwriters of their over-allotment option to
purchase additional shares, at a price to the public of $27.00 per
share.
- Nomination
of Roger M. Perlmutter for election to Board of Directors.
On April 28, 2021, NGM announced that the company has nominated
Roger M. Perlmutter, M.D., Ph.D. to stand for election to the
company’s board of directors at its June 8, 2021 annual meeting of
stockholders. Dr. Perlmutter brings decades of expertise and
renowned leadership in drug discovery and development with global
healthcare companies including Merck and Amgen.
- Extended
deadline for Merck collaboration extension notice. Merck
has a unilateral option to extend the research and early
development phase of its ongoing strategic collaboration with NGM,
which would, if exercised by Merck, extend the research phase of
the collaboration for an additional two-year period from March 2022
to March 2024. Merck was required to notify NGM of its unilateral
decision whether to exercise its option in March 2021, but in order
to allow the parties to negotiate potential modifications to the
terms of the collaboration agreement, on March 12, 2021, Merck and
NGM agreed to extend the deadline for Merck’s decision until June
30, 2021. NGM expects that any modified collaboration would result
in a level of annual research support from Merck during any
extension of the current research phase after March 2022 that is
meaningfully lower than the annual research support Merck provided
NGM during the initial five-year term and the first extension
period. NGM also expects that if Merck and NGM are unable to reach
agreement on modified terms, Merck will not elect to extend the
research phase of the collaboration and that NGM’s obligation to
fund its own research and development efforts will substantially
increase after March 2022.
First Quarter 2021 Financial Results
- NGM reported a net
loss of $27.5 million for the quarter ended March 31,
2021, compared to a net loss of $19.1 million for the same period
in 2020.
- Related party
revenue from our collaboration with Merck was $21.6 million for the
quarter ended March 31, 2021, compared to $24.4 million or the
same period in 2020. The decrease in related party revenue of $2.8
million in 2021 was primarily attributable to a decrease in the
recognition of the initial upfront payment received from Merck in
2015 that was included in the transaction price and fully
recognized by March 2020.
- Research and
development, or R&D, expenses were $40.7 million for the
quarter ended March 31, 2021, compared to $38.4 million
for the same period in 2020. R&D expenses increased $2.3
million in 2021, primarily due to a $3.5 million increase in
personnel-related expenses and an increase in external expenses
driven by our ongoing clinical and pre-clinical studies of NGM621,
NGM438 and NGM707. These increases were partially offset by a
decrease of $4.6 million in our manufacturing activities and
ongoing clinical trials of aldafermin and $1.2 million in
external expenses related to our other development programs.
- General and
administrative expenses were $8.7 million for the quarter
ended March 31, 2021, compared to $6.6 million for the
same period in 2020. The $2.1 million increase in general and
administrative expenses in 2021 was primarily attributable to
increases in personnel-related expenses driven by increased
headcount, as well as external expenses to support our operations
as a public company.
- Cash, cash
equivalents and short-term marketable securities were $412.7
million as of March 31, 2021, compared to $295.2 million as of
December 31, 2020.
Merck Collaboration
Under the current terms of NGM’s collaboration with Merck, Merck
has a one-time option to license NGM pipeline programs – other than
aldafermin, NGM386 and NGM395 – following human proof-of-concept
trials under the terms of the companies’ ongoing strategic
collaboration. Upon exercising any such option, Merck would lead
global product development and commercialization for the resulting
products, if approved. Prior to Merck initiating a Phase 3 study
for a licensed program, NGM may elect to either receive milestone
and royalty payments or to co-fund development and participate in a
global cost and revenue share arrangement of up to 50%. The current
terms of the collaboration also provide NGM with the option to
participate in the co-promotion of any co-funded program in the
United States. In January 2019, Merck exercised its first option
under the collaboration to license MK-3655, previously referred to
as NGM313. As described above, the parties continue to negotiate
potential modifications to the terms of the collaboration.
About NGM Biopharmaceuticals, Inc.
NGM is a biopharmaceutical company focused on discovering and
developing novel therapeutics based on scientific understanding of
key biological pathways underlying liver and metabolic diseases,
retinal diseases and cancer. We leverage our biology-centric drug
discovery approach to uncover novel mechanisms of action and
generate proprietary insights that enable us to move rapidly into
proof-of-concept studies and deliver potential first-in-class
medicines to patients. At NGM, we aspire to operate one of the most
productive research and development engines in the
biopharmaceutical industry. Visit us at www.ngmbio.com for more
information.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Words such as “anticipates,” “will,” “build,” “vision,”
“designed to,” “potential,” “aspire,” “continue,” “expect,” “plan”
and similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. These statements
include those related to NGM’s mission to build a biologic
therapeutics company that delivers lifechanging medicines for
patients; the availability and anticipated timing of topline data
from Phase 2b ALPINE 2/3 clinical trial of aldafermin and interim
results from the Phase 1a/1b dose-finding portion of the Phase 1/2
clinical trial of NGM120; the timing of initiation of Phase 1
clinical trials for NGM707 and NGM438 and NGM’s strategy to treat
cancer through myeloid reprogramming; the timing of completion of
enrollment in the Phase 2 CATALINA study of NGM621; the therapeutic
potential of NGM’s product candidates, including the potential for
every eight-week dosing for NGM621; NGM and Merck potentially
reaching agreement on the terms of a modified collaboration and
NGM’s expectations that any modified collaboration would result in
a meaningfully lower level of annual research support from Merck
during any extension of the current research phase, if any, and
that if Merck and NGM are unable to reach agreement on modified
terms, Merck will not elect to extend the research phase of the
collaboration and NGM’s obligation to fund its own research and
development efforts will substantially increase after March 2022;
Dr. Perlmutter’s potential election to NGM’s board of directors;
and other statements that are not historical fact. Because such
statements deal with future events and are based on NGM’s current
expectations, they are subject to various risks and uncertainties,
and actual results, performance or achievements of NGM could differ
materially from those described in or implied by the statements in
this press release. These forward-looking statements are subject to
risks and uncertainties, including, without limitation, risks and
uncertainties associated with the costly and time-consuming
pharmaceutical product development process and the uncertainty of
clinical success, including risks related to failure or delays in
successfully enrolling or completing clinical studies, the risk
that the results obtained to date in NGM’s clinical trials may not
be indicative of results obtained in subsequent pivotal or other
late-stage trials and the risk that NGM’s ongoing or future
clinical studies may show that aldafermin, or Merck’s ongoing or
future clinical studies of MK-3655, are not tolerable and effective
treatments for patients with NASH and the risk that its other
product candidates may also not be tolerable and effective
treatments in their planned indications; the risks that Merck may
elect not to extend the research phase of the collaboration and NGM
may otherwise be unable to reach agreement with Merck on the terms
of a modified collaboration and, regardless of whether NGM and
Merck reach agreement on the terms of a modified collaboration, NGM
expects that Merck will not provide research funding for certain of
NGM’s product candidates and the NGM’s collaboration with Merck
otherwise involves numerous other risks, any of which could
materially and adversely affect NGM’s business and financial
condition; the ongoing COVID-19 pandemic, which has adversely
affected, and could materially and adversely affect in the future,
NGM’s business and operations, including NGM’s clinical trials; the
time-consuming and uncertain regulatory approval process; NGM’s
reliance on third-party manufacturers for aldafermin and its other
product candidates; the sufficiency of NGM’s cash resources and
need for additional capital; and other risks and uncertainties
affecting NGM and its development programs, including those
discussed in the section titled “Risk Factors” in NGM’s annual
report on Form 10-K for the year ended December 31, 2020 filed with
the United States Securities and Exchange Commission (SEC) on March
15, 2021 and future filings and reports that NGM makes from time to
time with the SEC. Except as required by law, NGM assumes no
obligation to update these forward-looking statements, or to update
the reasons if actual results differ materially from those
anticipated in the forward-looking statements.
Investor Contact:Alex Schwartzir@ngmbio.com |
Media Contact:Liz Melonemedia@ngmbio.com |
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except share and per share
amounts)(Unaudited)
|
Three Months EndedMarch 31, |
|
2021 |
|
2020 |
Related party revenue |
$ |
21,575 |
|
|
|
$ |
24,364 |
|
|
Operating expenses: |
|
|
|
Research and development |
40,699 |
|
|
|
38,439 |
|
|
General and administrative |
8,721 |
|
|
|
6,595 |
|
|
Total operating expenses |
49,420 |
|
|
|
45,034 |
|
|
Loss from operations |
(27,845 |
) |
|
|
(20,670 |
) |
|
Interest income, net |
114 |
|
|
|
1,175 |
|
|
Other income, net |
187 |
|
|
|
380 |
|
|
Net loss |
$ |
(27,544 |
) |
|
|
$ |
(19,115 |
) |
|
Net loss per share, basic and
diluted |
$ |
(0.36 |
) |
|
|
$ |
(0.28 |
) |
|
Weighted average shares used
to compute net loss per share, basic and diluted |
76,034,145 |
|
|
|
67,396,229 |
|
|
|
|
|
|
|
|
|
|
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) (Unaudited)
|
March 31,2021 |
|
December 31,2020* |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
148,113 |
|
|
|
$ |
147,017 |
|
|
Short-term marketable securities |
264,543 |
|
|
|
148,139 |
|
|
Related party receivable from collaboration |
325 |
|
|
|
333 |
|
|
Related party contract asset |
4,600 |
|
|
|
6,100 |
|
|
Prepaid expenses and other current assets |
8,268 |
|
|
|
6,837 |
|
|
Total current assets |
425,849 |
|
|
|
308,426 |
|
|
Property and equipment, net |
13,733 |
|
|
|
14,526 |
|
|
Restricted cash |
1,499 |
|
|
|
1,499 |
|
|
Other non-current assets |
4,460 |
|
|
|
4,592 |
|
|
Total assets |
$ |
445,541 |
|
|
|
$ |
329,043 |
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
7,535 |
|
|
|
$ |
9,663 |
|
|
Accrued liabilities |
29,763 |
|
|
|
29,945 |
|
|
Deferred rent, current |
3,011 |
|
|
|
2,975 |
|
|
Total current liabilities |
40,309 |
|
|
|
42,583 |
|
|
Deferred rent, non-current |
5,655 |
|
|
|
6,417 |
|
|
Total liabilities |
45,964 |
|
|
|
49,000 |
|
|
Commitments and
contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, $0.001 par
value; |
— |
|
|
|
— |
|
|
Common stock, $0.001 par
value; |
77 |
|
|
|
71 |
|
|
Additional paid-in capital |
725,693 |
|
|
|
578,599 |
|
|
Accumulated other comprehensive income (loss) |
(18 |
) |
|
|
4 |
|
|
Accumulated deficit |
(326,175 |
) |
|
|
(298,631 |
) |
|
Total stockholders' equity |
399,577 |
|
|
|
280,043 |
|
|
Total liabilities and
stockholders' equity |
$ |
445,541 |
|
|
|
$ |
329,043 |
|
|
___________* Derived from the audited consolidated financial
statements.
NGM Biopharmaceuticals (NASDAQ:NGM)
Historical Stock Chart
From Aug 2024 to Sep 2024
NGM Biopharmaceuticals (NASDAQ:NGM)
Historical Stock Chart
From Sep 2023 to Sep 2024